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Body Contouring Gastric Balloon Clinical Trial

Orbera Clinical Trial

Diagram of gastric balloon in stomach

In the U.S. pivotal ORBERA™ clinical trial, a multicenter, prospective, randomized, non-blinded comparative study, patients suffering from obesity with a BMI between 30 and 40 were randomized to treatment or control in a 1:1 ratio. The treatment group underwent placement of the Orbera balloon followed by removal after 6 months. They concurrently participated in a 12-month behavioral modification program. The control group participated in the 12-month behavioral modification program alone. For patients in the treatment group, the device was removed at month 6, with regular office visits continuing through 1 year.

A total of 125 patients were randomized to the treatment group and 130 patients were randomized to the control group.

Detailed findings from the trial include:

  • At month 6, the Orbera group achieved a mean of 38.4% Excess Weight Loss (EWL).
  • Mean Total Body Weight Loss (TBWL) at 6 months was 10.2% for the treatment group compared to 3.3% TBWL for the control group.
  • The Orbera group lost 3.1 times as much weight as the control group at 6 months.
  • The Orbera group also lost significantly more weight than the control group over the course of the study, and was able to maintain significant weight loss through month 12, 6 months after removal of the device.